BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Materialise PKA Guides

    Reg #: 3009555447 · FEI: 3009555447 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Materialise Sdn Bhd
    Registration Number
    3009555447
    FEI Number
    3009555447
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 5-01, Menara Obyu, No. 4, Jalan PJU 8/8A, Damansara Perdana,
    City
    Petaling Jaya Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K202207

    Owner / Operator

    Firm Name
    MATERIALISE N.V.
    Operator Number
    9029485
    Address
    Technologielaan 15, --
    City
    Leuven
    State
    BE-NOTA
    Postal Code
    3001
    Country
    BE

    US Agent

    Business Name
    Materialise USA
    Contact Name
    Jenny Jones
    Address
    44650 Helm Court
    City
    Plymouth
    State
    MI
    ZIP
    48170
    Country
    US
    Email
    [email protected]
    Phone
    734 2597017

    Products

    Device Name Product Code
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    Materialise PKA Guides Zimmer Biomet Patient Specific Instruments SurgiCase Knee Planner Materialise PKA Guide System Materialise PKA Models

    Establishment Types

    Manufacture Medical Device